News & Events

C-Path Receives Letter of Support from EMA on Type 1 Diabetes Biomarker Initiative

    TUCSON, Ariz., April 28, 2020 — The Critical Path Institute (C-Path) today announced that its Type 1 Diabetes (T1D) Consortium has received a letter of support from the European Medicines Agency (EMA) to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to […]

C-Path Awarded FDA Contract to Enhance the Assessment of Clinical Outcomes in Pediatric Asthma Treatment Trials

The Critical Path Institute (C-Path) announced today it has been awarded a U.S. Food and Drug Administration (FDA) contract in support of ongoing development of novel clinical outcome assessments for pediatric asthma. C-Path’s Patient-Reported Outcome (PRO) Consortium will carry out this work through its Pediatric Asthma Working Group. Specifically, these assessments are intended to facilitate innovative patient-focused drug development and aid regulatory decision making by filling an unmet measurement gap.

ePRO Consortium Announces Open Access Article

In collaboration with the DIA Study Endpoints Community, C-Path’s ePRO Consortium is pleased to announce the open access article “Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials” is available online in the April 1, 2020 issue of Contemporary Clinical Trials. This article provides recommendations for the structure and content of an evidence dossier aimed at supporting a clinical trial endpoint derived from mobile sensor data as fit-for-purpose in regulatory decision making. Link to article:

C-Path Receives FDA Grant to Establish Rare Disease Clinical Outcome Assessment Consortium

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research has funded a cooperative agreement to establish a Rare Disease Clinical Outcome Assessment Consortium. The grant was awarded to C-Path with the NORD as a sub-awardee. The first step taken toward the establishment of the new consortium has been the creation of the Rare Disease Subcommittee within C-Path’s Patient-Reported Outcome (PRO) Consortium.